- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04732988
A Study to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Food Effect of HSG4112
October 25, 2021 updated by: Glaceum
A Dose-block Randomized, Double-blind, Placebo-controlled, Single and Multiple Dosing, Dose-escalation Phase I Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetic/Pharmacodynamic Characteristics, and Food Effect of HSG4112 After Oral Administration in Healthy and Obese Male Subjects
- Study Objective: The objective of this phase 1 clinical trial is to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic characteristics and food effect of HSG4112 after oral administration in healthy male subjects.
- Study Design and Plan: This study is a dose-block randomized, double-blind, placebo-controlled, single and multiple dosing, dose-escalation phase 1 clinical trial. A unique randomization number will be assigned to each subject deemed eligible to participate in the study based on the inclusion/exclusion criteria. Each subject will be randomized to one of the six groups for the single ascending dose (SAD) study or one of the three groups for the multiple ascending dose (MAD) study. Each dose group will consist of ten subjects, and among the ten subjects, eight subjects will be randomized to receive HSG4112 and two subjects will be randomized to receive placebo. The subjects will be studied in a double-blind manner and will receive the investigational product (i.e., HSG4112 or placebo) via once-daily oral administration. The dosing duration for the MAD study is 14 days. When escalating the dose, the Investigator will review all of the available safety data from the preceding dose in a blinded manner to ensure if it is safe to escalate the dose. In order to evaluate safety and tolerability, assessments, such as vital signs, 12-lead electrocardiogram, laboratory test, semen analysis (MAD study only), physical examination, and adverse event monitoring will be performed. Blood samples will be collected to evaluate the pharmacokinetic/pharmacodynamic characteristics of HSG4112.
Study Overview
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Daegu, Korea, Republic of, 41944
- Kyungpook National University Hospital
-
Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Able to comprehend and willing to sign an informed consent form approved by the IRB before screening.
- Males between 19 and 50 years of age at screening.
Body mass index (BMI) between 18 and 24.9.
☞ BMI (kg/m2) = Body weight (kg) / {Height (m)2}
- In good health, determined by no clinically significant findings from medical history, physical examination, vital signs, 12-lead electrocardiogram, and clinical laboratory test at screening, or subjects who are deemed acceptable by the Investigator regardless of the test results.
Exclusion Criteria:
- Significant history or clinical manifestation of any hepatic, kidney, neurological, immune, respiratory, endocrine, hematological, neoplastic, or cardiovascular disease, or psychiatric disorder (e.g., mood disorder, obsessive-compulsive disorder).
- History of stomach or intestinal disorders (e.g., Chrons disease, ulcer) or surgeries - not including appendectomy, hemorrhoidectomy, or herniotomy - which may affect the pharmacokinetic or pharmacodynamic evaluation of the investigational product.
- Significant history or clinical manifestation of hypersensitivity to any drug compound (e.g., licorice, aspirin, antibiotics).
One of more of the following laboratory test results at screening:
- ALT (SGPT) > 60 IU/L
- Glucose (fasting) > 110 mg/dL or < 70 mg/dL
- Testosterone <2.49 ng/mL or > 8.36 ng/mL
- Systolic blood pressure of < 90 mmHg or > 150 mmHg, or diastolic blood pressure of < 60 mmHg or > 100 mmHg as determined by vital signs monitored after resting in sitting position for at least 3 minutes.
- History of drug/chemical abuse or tested positive in urine drug screen.
- Use or intend to use any prescription medications/products or phytotherapeutic/herbal/plant-derived preparations within 14 days prior to dosing, or any nonprescription medications/products (i.e., over-the-counter (OTC) drugs), health products, or vitamins within 7 days prior to dosing, unless deemed acceptable by the Investigator.
- Participation in any clinical study or bioequivalence study involving administration of an investigational drug, including any study investigating HSG4112, within 6 months prior to dosing (i.e., within 6 months of the last dose from the previous study).
- Whole blood donation within 2 months prior to dosing, plasma/platelet donation within 1 month prior to dosing, or receipt of blood products within 1 month prior to dosing, or receipt of blood products within 1 month prior to dosing.
- Alcohol consumption of > 20 units/week (1 unit = 10 g of pure alcohol) or unable to abstain from consuming alcohol during the study period.
- Smoked within 90 days prior to dosing. However, participation is acceptable if the subject has quit smoking at least 90 days prior to dosing.
- Smoker. However, participation is acceptable if the subject has quit smoking at least 3 months prior to dosing.
- Ingestion of grapefruit-containing foods or beverages 24 hours prior to dosing until discharge, or unable to abstain from ingesting such foods or beverages during the same period.
- Unable to abstain from caffeine-containing foods or beverages (e.g., coffee, tea (e.g., black tea, green tea), soft drinks, coffee milk, energy drinks, sports drinks) during the admission period.
Unable or unwilling to use acceptable contraceptive methods during the study period.
☞ Acceptable contraceptive methods include:
- Use of an intrauterine device, which has been proven highly effective, by the subject's spouse/partner.
- Physical contraception for subject or spouse/partner used with chemical sterilization.
- Surgical sterilization (e.g., vasectomy, hysterectomy, tubal ligation, salpingectomy) of the subject or the subject's spouse/partner.
- Subjects who, in the opinion of the Investigator, should not participate in this study based on clinical laboratory test results or other reasons.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: HSG4112 30 mg Single Dose
Single oral dosing of HSG4112 30 mg
|
Once-daily oral administration
Other Names:
|
PLACEBO_COMPARATOR: Placebo 30 mg Single Dose
Single oral dosing of Placebo 30 mg
|
Once-daily oral administration
|
EXPERIMENTAL: HSG4112 60 mg Single Dose
Single oral dosing of HSG4112 60 mg
|
Once-daily oral administration
Other Names:
|
PLACEBO_COMPARATOR: Placebo 60 mg Single Dose
Single oral dosing of Placebo 60 mg
|
Once-daily oral administration
|
EXPERIMENTAL: HSG4112 120 mg Single Dose
Single oral dosing of HSG4112 120 mg
|
Once-daily oral administration
Other Names:
|
PLACEBO_COMPARATOR: Placebo 120 mg Single Dose
Single oral dosing of Placebo 120 mg
|
Once-daily oral administration
|
EXPERIMENTAL: HSG4112 240 mg Single Dose (Fasted)
Single oral dosing of HSG4112 240 mg under fasted conditions
|
Once-daily oral administration
Other Names:
|
EXPERIMENTAL: HSG4112 240 mg Single Dose (Fed)
Single oral dosing of HSG4112 240 mg under fed conditions
|
Once-daily oral administration
Other Names:
|
PLACEBO_COMPARATOR: Placebo 240 mg Single Dose
Single oral dosing of Placebo 240 mg
|
Once-daily oral administration
|
EXPERIMENTAL: HSG4112 480 mg Single Dose
Single oral dosing of HSG4112 480 mg
|
Once-daily oral administration
Other Names:
|
PLACEBO_COMPARATOR: Placebo 480 mg Single Dose
Single oral dosing of Placebo 480 mg
|
Once-daily oral administration
|
EXPERIMENTAL: HSG4112 720 mg Single Dose
Single oral dosing of HSG4112 720 mg
|
Once-daily oral administration
Other Names:
|
PLACEBO_COMPARATOR: Placebo 720 mg Single Dose
Single oral dosing of Placebo 720 mg
|
Once-daily oral administration
|
EXPERIMENTAL: HSG4112 240 mg Multiple Dose
Once-daily multiple oral dosing of HSG4112 240 mg for 14 days
|
Once-daily oral administration
Other Names:
|
PLACEBO_COMPARATOR: Placebo 240 mg Multiple Dose
Once-daily multiple oral dosing of Placebo 240 mg for 14 days
|
Once-daily oral administration
|
EXPERIMENTAL: HSG4112 480 mg Multiple Dose
Once-daily multiple oral dosing of HSG4112 480 mg for 14 days
|
Once-daily oral administration
Other Names:
|
PLACEBO_COMPARATOR: Placebo 480 mg Multiple Dose
Once-daily multiple oral dosing of Placebo 480 mg for 14 days
|
Once-daily oral administration
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 Over Dosing Interval
Time Frame: Hour 0 to 24
|
Area under the plasma concentration-time curve of HSG4112 over dosing interval (AUCtau)
|
Hour 0 to 24
|
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to the Last Measurable Point
Time Frame: Hour 0 to 192
|
Area under the plasma concentration-time curve from time zero to the last measurable point (AUClast)
|
Hour 0 to 192
|
Pharmacokinetic Assessment by Maximum Plasma Concentration of HSG4112
Time Frame: Hour 0 to 192
|
Maximum plasma concentration of HSG4112 (Cmax)
|
Hour 0 to 192
|
Pharmacokinetic Assessment by Area Under the Plasma Concentration-Time Curve of HSG4112 from Time Zero to Infinity
Time Frame: Hour 0 to 192
|
Area under the plasma concentration-time curve from time zero to infinity (AUCinf)
|
Hour 0 to 192
|
Pharmacokinetic Assessment by Time to Maximum Observed Plasma Concentration of HSG4112
Time Frame: Hour 0 to 192
|
Time to maximum observed plasma concentration of HSG4112 (Tmax)
|
Hour 0 to 192
|
Pharmacokinetic Assessment by Half-Life of HSG4112
Time Frame: Hour 0 to 192
|
Half-life of HSG4112 (T1/2)
|
Hour 0 to 192
|
Pharmacokinetic Assessment by Oral Clearance of HSG4112
Time Frame: Hour 0 to 192
|
Oral clearance of HSG4112 (CL/F)
|
Hour 0 to 192
|
Pharmacokinetic Assessment by Volume of Distribution of HSG4112
Time Frame: Hour 0 to 192
|
Volume of distribution of HSG4112 (Vd/F)
|
Hour 0 to 192
|
Safety and Tolerability Assessment by Number of Participants with Change in Vital Signs
Time Frame: Up to 3 weeks from day of last dosing
|
Number of participants with clinically significant change in vital signs including blood pressure (mmHg) measured with blood pressure monitor, heart rate (beats per minute) measured with pulse oximeter, and body temperature (degrees Celcius) measured with thermometer
|
Up to 3 weeks from day of last dosing
|
Safety and Tolerability Assessment by Number of Participants with Change in 12-Lead Electrocardiogram
Time Frame: Up to 3 weeks from day of last dosing
|
Number of participants with clinically significant change in 12-lead electrocardiogram
|
Up to 3 weeks from day of last dosing
|
Safety and Tolerability Assessment by Number of Participants with Change in Laboratory Test
Time Frame: Up to 3 weeks from day of last dosing
|
Number of participants with clinically significant change in laboratory test assessed through hematology, blood biochemistry, urinalysis, and blood coagulation test
|
Up to 3 weeks from day of last dosing
|
Safety and Tolerability Assessment by Number of Patients with Change in Physical Examination
Time Frame: Up to 3 weeks from day of last dosing
|
Number of participants with clinically significant change in physical examination
|
Up to 3 weeks from day of last dosing
|
Safety and Tolerability Assessment by Number of Patients with Change in Semen Volume
Time Frame: Up to 12 weeks from day of last dosing
|
Pre-to-post examination of semen volume (milliliters) by semen analysis to assess the safety and tolerability of HSG4112
|
Up to 12 weeks from day of last dosing
|
Safety and Tolerability Assessment by Number of Patients with Change in Semen White Blood Cells
Time Frame: Up to 12 weeks from day of last dosing
|
Pre-to-post examination of semen white blood cells (10^3 per microliter) by semen analysis to assess the safety and tolerability of HSG4112
|
Up to 12 weeks from day of last dosing
|
Safety and Tolerability Assessment by Number of Patients with Change in Sperm Count
Time Frame: Up to 12 weeks from day of last dosing
|
Pre-to-post examination of sperm count (10^6 per milliliter) by semen analysis to assess the safety and tolerability of HSG4112
|
Up to 12 weeks from day of last dosing
|
Safety and Tolerability Assessment by Number of Patients with Change in Sperm Motility
Time Frame: Up to 12 weeks from day of last dosing
|
Pre-to-post examination of sperm motility (percent of sperm with normal motility) by semen analysis to assess the safety and tolerability of HSG4112
|
Up to 12 weeks from day of last dosing
|
Safety and Tolerability Assessment by Number of Patients with Change in Sperm Morphology
Time Frame: Up to 12 weeks from day of last dosing
|
Pre-to-post examination of sperm morphology (percent of normal sperm) by semen analysis to assess the safety and tolerability of HSG4112
|
Up to 12 weeks from day of last dosing
|
Safety and Tolerability Assessment by Adverse Event Monitoring
Time Frame: Up to 12 weeks from day of last dosing
|
Number of participants with observed adverse events
|
Up to 12 weeks from day of last dosing
|
Safety and Tolerability Assessment by Number of Patients with Change in Semen pH
Time Frame: Up to 12 weeks from day of last dosing
|
Pre-to-post examination of semen white blood cells (10^3 per microliter) by semen analysis to assess the safety and tolerability of HSG4112
|
Up to 12 weeks from day of last dosing
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacodynamic Assessment by Change of Biomarkers
Time Frame: Day 1 and 14 pre-dose
|
Measurement of biomarkers including leptin, adiponectin, insulin, C-peptide (connecting peptide), IL6 (interleukin 6), TNF-alpha (tumor necrosis factor alpha), and CCL2 (C-C motif ligand 2) from baseline to day of last dosing will be combined to assess the weight loss effect of HSG4112
|
Day 1 and 14 pre-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 23, 2018
Primary Completion (ACTUAL)
May 24, 2021
Study Completion (ACTUAL)
May 24, 2021
Study Registration Dates
First Submitted
January 19, 2021
First Submitted That Met QC Criteria
January 29, 2021
First Posted (ACTUAL)
February 1, 2021
Study Record Updates
Last Update Posted (ACTUAL)
November 1, 2021
Last Update Submitted That Met QC Criteria
October 25, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- HSG4112-P1-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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